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Zofran Lawsuit FAQs

Zofran Birth Defect Lawsuit Rosenfeld Injury Lawyers LLC represents people with Zofran injuries who were harmed after taking bad medications prescribed by their doctor. Our law firm has collected a series of Zofran lawsuit accident FAQs related to the medical and legal aspects of dealing with the serious side effects of taking a dangerous medication. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.

Zofran Lawsuit Frequently Asked Questions

Our pharmaceutical litigation attorneys have resolved dozens of cases involving victims and surviving family members who have suffered damages caused by using Zofran. Our law firm understands that GlaxoSmithKline, the drug manufacturer, marketed the product knowing it had dangerous, life-threatening side effects.

The harmful drug injury attorneys at Rosenfeld Injury Lawyers LLC have compiled a comprehensive list of the most frequently asked questions involving Zofran lawsuits and posted the answers below. Many families use this information to determine how to take legal action for justice and to obtain the financial compensation they deserve for their injuries and damages.

What is Zofran and why is it used?

Doctors prescribe Zofran (ondansetron) to treat anti-nausea for patients undergoing cancer-related radiation and chemotherapy treatments. The medication has been shown to prevent nausea after a surgical procedure. The Food and Drug Administration (FDA) approved the drug for these uses but still requires listing side effect warnings for patients and doctors.

Are Zofran and ondansetron the same medication?

Zofran is a brand-name medication manufactured by GlaxoSmithKline. However, other drugs contain the same active ingredients formulated with the same protein binding, half-life and bioavailability properties. These other drugs include Ondisolv and the generic form ondansetron.

How does the medication work?

The medication was designed to partially block the production of serotonin, a chemical produced by the brain required for body function and nausea response. However, the FDA did not approve Zofran or its generic counterpart ondansetron for use during pregnancy. Even so, many physicians, gynecologist, and obstetricians have prescribed Zofran for the “off-label” use or treating severe morning sickness suffered by pregnant women.

Is the medication unsafe to use during pregnancy?

Yes. The Food and Drug Administration has yet to approve Zofran for an off-label use during pregnancy. Recent studies revealed that the medication is considered unsafe for expecting mothers. The federal agency cautioned doctors against prescribing Zofran or the generic ondansetron for any patients suffering from an electrolyte abnormality. This caution extends to pregnant women who tend to experience electrolyte imbalance. Some research revealed horrific Zofran side effects when used during the first trimester of pregnancy that has resulted in severe birth defects.

If the drug is problematic during pregnancy, why do doctors still prescribed Zofran?

That is a good question. Many doctors continue to prescribe numerous drugs to pregnant mothers even though these medications have yet to be approved by the FDA for use during pregnancy. Up until April 2013, there was no anti-nausea medication approved by the Food and Drug Administration for expecting mothers suffering from severe morning sickness. During this time, some doctors chose to prescribe Zofran (ondansetron) to treat the condition without FDA approval. Since then, both pyridoxine and doxylamine received approval from the federal agency to treat vomiting and nausea during pregnancy. Even though other options are available, many doctors continue to prescribe Zofran for “off-label” use.

What are the known congenital disabilities associated with Zofran?

Recent studies have revealed there is an increased potential risk of a fetus developing a severe birth defect when the mother took Zofran (ondansetron) during the early months of pregnancy. Common congenital disabilities associated with Zofran use include heart defects where a hole develops between the center of the heart and the heart's chambers, along with cleft lip and cleft palate (craniofacial defects), skull deformities, clubfoot, and kidney malformation defects.

I am taking Zofran while pregnant. Is my child in danger of developing a birth defect?

The risk of your newborn developing a congenital disability if you took Zofran is low. On average, the number of newborns born a cleft palate is approximately one out of every 2500, which rises to two or three out of 2500 if the mother took Zofran (ondansetron) while pregnant. However, the risk of your child being born with a heart defect if you took Zofran while pregnant is approximately double (two and 100) compared to mothers who did not take the medication during their pregnancy.

Are any heart problem side effects life-threatening to adults who take Zofran?

Possibly. In 2011, the Food and Drug Administration issued a Communication Warning identifying concerns about Zofran use. This information was updated in June 2012 when the FDA identified a correlation between health rhythm issues and taking the drug. The federal agency warned doctors and patients that Zofran (ondansetron) might affect the heart's QT interval prolongation electrical activity. This dangerous side effects could cause the patient to experience potentially fatal abnormal heart rhythms including Torsades de Pointes, a life-threatening type of polymorphic ventricular tachycardia.

What are the heart rhythm problematic symptoms associated with Zofran use?

In 2011, the Food and Drug Administration issued a public safety warning to inform patients using Zofran (ondansetron) that their prescribing physician might order an electrocardiogram to identify heart rate and heart rhythm problems. The safety warning advised patients to get medical attention immediately if they experienced any heart rhythm issue problems including:

  • Irregular heart rhythm
  • Fainting
  • Shortness of breath
  • Dizziness

Has the Government taken any action against the drug manufacturer?

Yes. In 2012, the US Department of Justice announced through a press release that GlaxoSmithKline (GSK), the manufacturer of Zofran, had agreed to pay a $3-billion settlement and plead guilty to criminal charges. The agreement stipulated that the drug manufacturer failed to report safety data to the Food and Drug Administration and had unlawfully promoted the prescription drug in the medical marketplace. The manufacturer also agreed to false price reporting. The Zofran manufacturer made the most substantial payment ever in the United States to settle a health care fraud case.

I have been damaged after taking Zofran (ondansetron). What can I do?

If you have suffered an injury after taking Zofran or its generic equivalent ondansetron, you had the legal right to file a claim for compensation against the drug manufacturer and others charged with ensuring patient safety. The product liability attorneys at Rosenfeld Injury Lawyers LLC have represented many clients in pursuing the financial compensation they deserve to recover their economic and non-economic damages.

Our attorneys can determine if you have a valid case for compensation by reviewing the mother and child's Medical Records. If the infant was born with a cleft palate or cleft lip or diagnosed with the heart defect, you likely have a compelling, provable case for filing and successfully resolving a claim for compensation against Glaxo SmithKline.

Our family feels uncomfortable about suing. Is that our only option?

If you suffered a severe health problem or your child developed a birth injury from Zofran use, you likely are facing lifelong medical care needs that could be very expensive. The impact on your family could place a physical, emotional and financial burden that is difficult to overcome without monetary assistance.

It is important to remember that you are not responsible for the negligent actions of the drug manufacturer who generated millions of dollars in profits and has access to vast resources. The pharmaceutical drug maker failed to protect you or your child against the dangerous side effects they knew could cause harm.

Filing a lawsuit or claim for compensation can serve justice by exposing that the pharmaceutical manufacturer knew the pain, suffering and severe side effects their defective product creates. Unfortunately, medication lawsuit litigation is your only legal option to seek a negotiated settlement or a jury trial award. Successfully resolving your case will not only compensate your family for the damages you have endured but protect others in the future that can avoid the unexpected consequences of taking a defective medication.

How much would my case be worth?

The uniqueness of the circumstances, facts, and evidence involved in the damage you experienced from taking Zofran (ondansetron) makes it difficult to determine the worth of your case precisely. The amount plaintiffs receive in a settlement, or a jury trial award varies between cases. Our attorneys will construct your legal argument on the evidence and testimony that can be proved in court or during negotiation meetings when attempting to settle out of court.

When proving your case to the claims adjuster, the defendant's attorneys, or the jury, our lawyers will present evidence to consider including:

  • The extent, intensity, and duration of all congenital disabilities that occurred from taking Zofran (ondansetron) including the cost of medical care, surgical procedures, physical therapy, and treatment required to maintain a healthy life

  • The damaging effect on the child who developed a birth defect after the mother took Zofran including their overall mental and physical health

  • The mental anguish, pain and suffering the child has experienced and will likely encounter many years in the future

  • Every long-term injury that affects the child's future physical and mental health and their ability to enjoy a long life

Our attorneys will fight aggressively on your behalf to ensure that your Zofran lawsuit is resolved successfully to ensure that your family receives adequate compensation. Your compensation will recover all your damages and provide sufficient money to relieve the future financial burden on your family and ensure your child enjoys the remainder of his or her life.

Do I need to file my claim in multidistrict court?

Possibly. Today, many Zofran cases are handled in a Massachusetts centralized federal court and heard under the multidistrict litigation (MDL) process. The federal judge oversees every national case to ensure the decisions in pretrial matters have uniformity in future cases. The initial bellwether trials will help develop a foundation of how much plaintiffs in future cases will receive to ensure they are adequately compensated for their damages.

Currently, the MDL court is in the process of determining whether GlaxoSmithKline failed in their duties to protect patients using their medications including Zofran as intended and in “off-label” use. Many injured plaintiffs have filed lawsuits making claims that the drug manufacturer:

  • Unlawfully marketed, promoted and encouraged doctors to prescribe the medication to expecting mothers for “off-label” use.

  • Concealed the evidence that revealed that Zofran was known to increase the potential risk of a fetus developing a congenital disability.

  • Failed to warn doctors, pregnant mothers and the public of the alleged associated risks of taking Zofran because of its known severe side effects.

Our family is ready to file a lawsuit. How much will you charge to review our case?

Our law firm provides every potential client a no-obligation, initial case consultation at no charge. Call our law offices today at (888) 424-5757 to schedule an appointment. Let our team of attorneys discuss your case, listen to your complaints, and provide numerous legal options on how to ensure your family receives the financial compensation they deserve.

We do not have any savings to hire a lawyer. What can we do?

The dangerous drug attorneys at Rosenfeld Injury Lawyers LLC accept all compensation cases through contingency fee agreements. This agreement postpones payment of legal fees until our law firm successfully resolves your Zofran lawsuit through a negotiated settlement or wins your lawsuit at trial.

If you suspect taking Zofran caused you or your child harm, our attorneys urge you to contact us today at (888) 424-5757 to schedule your free, no-obligation comprehensive claim evaluation. We have successfully prosecuted Zofran lawsuits like yours. Our lawyers provide every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf, you owe us nothing. Call us now so we can begin working on your case today.

Learn more about our Zofran litigation practice by visiting our page here.

Follow the links below to access the specific Zofran pages addressing:

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